You may be comforted to know that doctors and scientists are working diligently at finding new and better ways to treat, prevent, and screen for prostate cancer as well as to enhance the quality of life for prostate cancer patients. This work is done through clinical trials.

What is a clinical trial?

After a new drug or treatment has first been observed by a physician, tested theoretically in a laboratory or with animal studies, if it still shows promise, researchers will develop a plan (also called a protocol) to test its effectiveness in people.

What are the clinical phases?

Clinical trials are typically done in three phases. The first phase tests the safety of the drug or the treatment and usually involves a small group of patients. The second phase tests the effectiveness of the drug or treatment and usually involves many more patients with a well-defined problem. If the second phase results remain promising, the trial will proceed to a third phase where potentially hundreds or even thousands of patients will be involved.

In the third phase of a clinical trial researchers will want to compare whether or not a new treatment might be better than a current standard treatment and will split participants into groups. Much care will be taken to assure that the trial is not biased in anyway. Participants will not know which group they belong to and often the medical staff will not know either. The “experimental group” will receive the new treatment and the “control group” will receive the best available standard treatment.

Where are they conducted?

Trials are often conducted at many different sites where each doctor is expected to follow the plan or protocol of the trial precisely. Clinical trials are carefully designed to minimize risks and maximize benefits. All trial plans go before an ethics or review committee to ensure that the trial poses no unreasonable risks to the participants.

Do I have to accept even if I do not want to?

Participation in a clinical trial is voluntary; this means it is your choice whether you want to participate. If you do, you will be informed completely of all aspects of the trial. You will be asked to sign a consent form stating that you have been informed and understand what the trial is about. Even if you have initially agreed to participate in a trial, you can drop out of it at any time.

Many men like participating in trials because they wish to advance medical science and improve the prospects for future generations of patients. Others like to participate because there is a chance that they might have access to a new treatment or drug before they are publicly available. Still others find it assuring to be closely monitored while involved in a trial.

Will my health be at risk?

Research has found that people receiving treatment within trials tend to do better than similar patients outside of trials. However, this does not mean that trial treatments are better. There could be many other factors as to why patients do better such as, having access to good equipment or having doctors who follow precise guidelines when providing the treatment.

Whatever your reason is for participating in a trial you must understand what potential risks or inconveniences might be involved. What follows are some questions you may want to ask in order to help you feel comfortable with whatever decision you take.

Questions to ask before Joining a Clinical Trial

• Why is this clinical trial being conducted?
• What are its aims?
• How might it help me and will it help other people?
• How long will the clinical trial last, and what time commitment will it require from me?
• Will I need to take time off from work?
• Will it involve many extra visits to the hospital/clinic?
• What extra tests will I need to have?
• Will there be any costs to me involved in this?
• What are the possible side effects of the treatment?
• Are the treatments going to affect me emotionally?
• Will I be required to answer many questionnaires or keep track of things in a diary/log?
• Who will know I am in the clinical trial and what will they be told about me?
• Should I run into a problem, will there be someone available around the clock for me to contact?

To learn more about clinical trials, speak with your healthcare team. For more information on clinical trials, visit:

• Clinical trials: www.clinicaltrials.gov
• Canadian Cancer Trials: canadiancancertrials.ca